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October 28, 2013

In responding to Myriad Genetics'
complaint for patent infringement, both Ambry Genetics and Gene-by-Gene asserted counterclaims under the Sherman Antitrust Act, predicated on
Myriad's filing its patent infringement lawsuit. Myriad filed motions with the District Court to dismiss these antitrust counterclaims under Fed. R. Civ Pro 12(b)(6)
for failure to state a claim upon which relief can be granted, which Ambry and
Gene-by-Gene have jointly opposed. The basis for Myriad's motion is that filing lawsuits against these
alleged infringers is immune from antitrust liability under the
Noerr-Pennington doctrine, that neither Defendant has shown that Myriad's
patent infringement allegations amount to sham litigation, and procedurally that
neither Defendant has satisfied the pleadings requirements set forth by the
Supreme Court under Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570
(2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). Both Plaintiff's and Defendants' arguments
ultimately depend on how the District Court will view the interpretation of the Supreme
Court's decisions in its Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
132 S.Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad
Genetics, Inc., 133 S.Ct. 2107 (2013), cases.

Defendants' brief opposing Myriad's motion
to dismiss relies on two principles:first, procedurally, that their complaint
alleges sufficient facts to satisfy the Supreme Court's Twombly and Iqbal standards;
and substantively, that Myriad's complaint is not entitled to Noerr-Pennington antitrust immunity
because the litigation is a sham in view of the Court's recent Mayo and Myriad decisions. The Noerr-Pennington
doctrine of antitrust immunity, which arises from two Supreme Court cases: Eastern R.R. Presidents Conference v. Noerr Motor Freight,
Inc., 365 U.S. 127, 136, 81 S.Ct. 523
(1961), and United Mine Workers v. Pennington, 381 U.S. 657, 85 S.Ct. 1585 (1965),
stands for the proposition that a party has the right
to petition its government for redress of grievances or to influence public
officials is protected activity that cannot raise antitrust liability. These activities include, inter alia, filing suit including patent
infringement lawsuits. However, there
are exceptions to this immunity, including asserting claims obtained through
inequitable conduct (Walker Process Equip., Inc. v. Food
Mach. & Chem. Corp., 382 U.S. 172, 175-77
(1965); accordingly "Walker Process fraud") or when the
lawsuit is "objectively basis" or constitutes "sham litigation." Neither Ambry nor Gene-by-Gene have
alleged Walker Process fraud against
any of Myriad's patents.

Substantively, Defendants argue
that Myriad is not immunized under the Noerr-Pennington
doctrine because Myriad's asserted claims are facially invalid under the
Supreme Court's Mayo and Myriad decisions, and thus these
lawsuits are brought in bad faith. Defendants cite case law (albeit not from the 10th Circuit or
Supreme Court) that make satisfaction of the objective prong of the sham
litigation test apparently easier to satisfy than the precedent cited by Myriad
in its motion to dismiss; indeed, Defendants even cite a DC District Court case
(WAKA LLC v. DC Kickball, 517 F.Supp.2d 245, 251 (D.D.C. 2007)) that "the
mere invocation of 'sham litigation' is enough to state a claim and survive
dismissal (although this case was decided prior to either the Twombly or Iqbal decisions). More
convincingly, Defendants also cite 10th Circuit precedent that
whether a suit is objectively baseless involves subjective factual
determinations of whether a plaintiff had "probable cause" to file
the lawsuit and that a motion to dismiss should be denied on those
grounds. Pers. Dept., Inc. v. Prof'l
Staff Leasing Corp., 297 Fed.Appx.
773, 780-81 (10th Cir. 2008).

Defendants recite a litany of
their factual allegations in this regard (supported by "over 30 pages of
factual allegations regarding Myriad's bad
faith conduct, spanning more than 100 paragraphs" in their counterclaim,
including:

• Myriad has in bad faith brought
this lawsuit against Defendants on patent claims that it knows are invalid
under two Supreme Court decisions and Federal Circuit authority.• Two decisions by the Supreme
Court, issued before plaintiffs brought this suit, rebut the presumption by
Myriad that it brought this suit in good faith: [Myriad] and Mayo.• According to the Federal
Circuit, with Mayo the Supreme Court "made clear that such
diagnostic methods in that case essentially claim natural laws that are not
eligible for patent."• The Supreme Court in AMP IV unanimously
held that isolated DNA is not patent eligible subject matter, which had the
effect of invalidating the claims Myriad currently asserts against Defendants.• The Supreme Court in [Myriad]
unequivocally excluded from patentable subject matter synthetic DNA "that
may be indistinguishable from natural DNA"; yet, Myriad is attempting to
enforce claims in the present litigation that have common subject matter to the
invalidated claims.• Myriad is asserting method
claims in the present litigation that are facially invalid in view of the
Supreme Court's decision in Mayo and the Federal Circuit's [two Myriad]
decisions.

Regarding the composition claims,
Defendants contend that these are invalid under the Supreme Court's Myriad decision, illustrating the
dispute (and the consequence of the Court's "less than pellucidly clear"
opinions on matters of patent law) in how the Court's language in its Myriad decision should be
interpreted. Myriad contends that the
synthetic nature of the probes and primers in its asserted composition claims
brings those claims within the ambit of subject matter the Court deemed patent
eligible, whereas Defendants argue that the patent eligibility question depends
on whether the sequence of the primers is identical to sequences found in
genomic DNA. Although Defendants may
have the better argument, Myriad relies on its assertion
of claim 6 of U.S. Patent No. 5,747,282 which was among the claims not
invalidated in the Court's opinion.

It is with regard to the method
claims that Defendants' arguments require the District Court to accept their
(perhaps) logical extension of the Court's Mayo
decision to extend to Myriad's asserted method claims and further to argue that
assertion of such claims is objectively baseless and brought in bad faith. This is certainly a question that needs
answering, and may in fact be answered in the course of this patent
infringement litigation. But the fact
that it needs to be answered undercuts Defendants' allegations that by bringing
the lawsuit(s) Myriad has shed its Noerr-Pennington
immunity and brought an objectively baseless lawsuit. And Defendants are themselves capable of
stretching the limits of the precedential value of the Myriad decisions, in their case regarding decisions by the Federal
Circuit. For example, their brief states
that:

The [second Federal
Circuit Myriad opinion] declared
invalid all method claims asserted in the AMP litigation except for
Claim 20 of the '441 patent. The method claims other than Claim 20 asserted in
the AMP litigation (and here) compare and analyze patient BRCA1 and
BRCA2 sequences. That subject matter was expressly declared invalid in [the
first and second Federal Circuit Myriad
opinions]. Importantly, Myriad did not appeal that aspect of [second Federal
Circuit Myriad opinion] to the
Supreme Court.

Missing from this analysis is that
Plaintiffs in the Myriad case deigned
not to challenge any of the method
claims now asserted by Myriad, and that the method claims invalidated in the
Myriad decisions were of a much broader and less specific scope than Myriad's
now-asserted claims. Thus, there is no direct precedential value of any of
the Myriad decisions to the question of whether assertion of Myriad's claims is
objectively baseless.

Finally, the brief notes that
several other competitors, including some (Counsyl, Quest, GeneDX) that Myriad
has also sued, entered the marketplace as evidence that Myriad's patents are
invalid; this at least raises a factual question as to the objective
baselessness of Myriad's complaint that Defendants argue is not appropriate for
summary dismissal under Fed. R. Civ. Pro. 12(b)(6). Hedging their bets, Defendants also ask for
leave to file an amended complaint should the District Court grant Myriad's
motion.

Comments

"Missing from this analysis is that Plaintiffs in the Myriad case deigned not to challenge any of the method claims now asserted by Myriad, and that the method claims invalidated in the Myriad decisions were of a much broader and less specific scope than Myriad's now-asserted claims."

Exactly what eligible, non-conventional, information-gathering steps are in these "more specific" claims that renders them eligible in view of Prometheus?

Do you any of the highly educated writers of this patent blog have any opinion as to whether the recitation of ineligible subject matter can turn a claim that would otherwise be anticipated (or obvious) into an eligible, enforceable claim?

I have no idea whether the claims are novel or non-obvious - that question hans't been litigated anywhere, and while it is recited as an affirmative defense by Ambry and Gene-by-Gene that isn't the point of the post. In their opposition they argue that Mayo and Myriad make the claims facially invalid under Section 101 and that thus Myriad loses its Noerr-Pennington immunity to antitrust liability. Like it or not, the ACLU and PubPat made a strategic decision to challenge claims not infringed by genetic diagnostic methods instead of the method claims Myriad now asserts. Put another way, had Plaintiffs in Myriad challenged claims including ones Myriad is now asserting we would have our answer. We don't.

The fact that you can make arguments that these claims are invalid or Myriad can make arguments that they are not is irrelevant. All they are are arguments, and unless and until a court determines that the synthesis you assert is the law that is all they are.

For what it's worth, I think there are a great many instances where conventional methods (such as formulation methods) are used to make novel and non-obvious pharmaceutical formulations/compositions based on novel compounds. And I think that pharmaceutical composition claims of putatively non-eligible natural products should be patent eligible, because otherwise we will have put doctrinal consistency in place of good sense. But that hasn't happened (yet) and I'm not about to leapfrog over those precedential steps to get to the conclusion you draw.

Ultimately your way may be the way it turns out. But it ain't necessarily so.

For a person who claims to be an expert (and indeed, I believe you've played on one TV and in the editorial pages of widely read newspapers), it's rather odd that you have "no opinion" on these fundamental patent questions surrounding an intellectual property in a dispute that you've been obsessing over for years. No opinion? That's funny.

"The fact that you can make arguments that these claims are invalid or Myriad can make arguments that they are not is irrelevant."

Sorry, Kevin, but the only arguments and opinions that are "irrelevant" are the ones that are never communicated to anyone.

I asked you a straightforward question and you chose to answer a different question. That's also not "irrelevant". Your opinion about how you wish the Prometheus case had turned out is well-known. But the rule in Prometheus is clear. Care to try answering the question I asked you again, keeping in mind the law that the Federal Circuit is obliged to follow?